JP2007244572A - Method for producing biological sensor - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method for producing a biological sensor having an attachment section which is attached stably to a specified part of the external ears of a plurality of persons and has high reproducibility regarding an attachment position. <P>SOLUTION: A biological sensor 91 for measuring biological information has the attachment section 13 attached to the external ear of a person. The method for producing the biological sensor is characterized that the shape of a part of the attachment section that comes into contact with a specified part 104 of the external ear is shaped according to an average shape of the specified parts 104 of the external ears of a plurality of persons. The specified part 104 is preferably located on an area from the ear canal 102 to the cavity of concha 103 on the back part of the head. By attaching the attachment section 13 on the specified part 104 of the external ear, the attachment position of a cuff 11 is determined uniquely, and the position of the cuff is prevented from being moved by body motion. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a method for manufacturing a biosensor that can be stably attached to an outer ear.

  With the aging of society, dealing with adult lifestyle-related diseases has become a major social issue. It is recognized that collection of long-term blood pressure values is very important, especially for diseases associated with high blood pressure. From such a point of view, a measuring apparatus that continuously measures biological information such as a blood pressure value, a pulse, a pulse wave, an electrocardiogram, a body temperature, or arterial oxygen saturation has been developed.

  As a measurement device that continuously measures biological information, there is a patient monitor device that is always attached to the ear canal (see, for example, Patent Document 1). This apparatus calculates a blood pressure value or the like from the amount of received infrared light or visible light scattered into the body. However, this patient monitor device does not show a specific configuration as a blood pressure measurement device.

Here, the names of the auricles are based on Non-Patent Documents 1, 2, and 3. The front side of the pinna is the side facing the face side of the pinna, and the back side of the pinna is the side facing the occipital side of the pinna. Further, the upper end portion of the pinna is the end on the parietal side at the boundary between the pinna and the temporal region. The lower end of the auricle is the end on the neck side at the boundary between the auricle and the temporal region.
JP-A-9-128203 Sobotta Illustrated Human Anatomy Volume 1 (Translation by Michio Okamoto), p. 126, Medical School, issued October 1, 1996 Sobotta Illustrated Human Anatomy Volume 1 (Translation by Michio Okamoto), p. 127, Medical School, issued October 1, 1996 Body map book (supervised and commentary by Nagao Takahashi), p. 20, Kodansha Co., Ltd., issued on January 29, 2004

  The outer ear or its surroundings are suitable for the measurement of blood pressure because there are few vibrations and changes in daily life compared to limbs and there are many relatively thick arteries and peripheral blood vessels near the epidermis. In order to compare blood pressure values, pulse wave reproducibility is required, but since there are many arteries in the outer ear, reproducibility of the wearing position is required. In particular, the wearing position may change with cuff pressure increase / decrease during blood pressure measurement. As a method for solving this, a method of providing a mounting portion for mounting the sphygmomanometer to the outer ear can be considered.

  Since the wearing part always wears the biosensor on the outer ear and continuously measures the blood pressure value, it is necessary to fix the position of the wearing part at a fixed position with as little stimulation as possible. However, the shape of the outer ear is complex and has great individual differences. For this reason, even if the mounting part is made by single size or shape or sizing according to simple parameters, it does not fit and the mounting position is not stable even if the mounting part is mounted on the human outer ear. There was a problem that easily shifted.

  On the other hand, if it is made in order to enhance the fit between the mounting portion and the outer ear, the shape of the specific part of the outer ear is measured for each individual, and the shape of the mounting portion is produced according to the measured shape. For this reason, since all the steps for producing the mounting portion must be performed for each person, a large production procedure is required to provide one sphygmomanometer.

  Therefore, an object of the present invention is to provide a method for producing a biosensor including a mounting portion that can be stably mounted on specific parts of a plurality of human outer ears and that has high reproducibility of mounting positions.

  In the method for producing a biosensor according to the present invention, the shape of the portion of the mounting unit that mounts the biosensor for measuring biometric information on the outer ear of a human being to be in contact with the specific part of the outer ear is specified for the plurality of human outer ears. It is characterized by having a shape along the average shape of the part.

  Specifically, the biosensor manufacturing method according to the present invention includes a shape acquisition procedure for acquiring a three-dimensional shape of specific parts of a plurality of human outer ears, and an average of the plurality of three-dimensional shapes acquired by the shape acquisition procedure. The average shape calculation procedure for calculating the shape, and the average shape calculated in the average shape calculation procedure for the shape of the portion that contacts the specific part of the outer ear of the wearing part that wears the biological sensor for measuring biological information on the outer ear And a mounting portion shape setting procedure for setting the shape in accordance with the shape.

  In the biosensor manufacturing method according to the present invention, in the average shape calculation procedure, the average shape of the plurality of three-dimensional shapes is calculated using a product-sum operation or morphing of the plurality of three-dimensional shapes acquired in the shape acquisition procedure. It is preferable to calculate. By using product-sum operation or morphing, a precise average shape of a three-dimensional shape can be calculated. Furthermore, by using a product-sum operation, the average shape can be calculated with a simple operation.

  In the biosensor manufacturing method according to the present invention, in the average shape calculation procedure, a plurality of planes forming the three-dimensional shape are extracted for each of the plurality of three-dimensional shapes acquired in the shape acquisition procedure, The average position where the distance from the center to the plane forming the other three-dimensional shape on the normal of the plane is an average is calculated for each plane, and the three-dimensional shape formed by the set of the average positions is An average shape is preferred. Since the average shape can be calculated by extracting the surface shape data of the three-dimensional shape, the data capacity for expressing the three-dimensional shape can be reduced.

  In the biosensor manufacturing method according to the present invention, in the average shape calculation procedure, a two-dimensional shape in a predetermined cross section is extracted for each of a plurality of three-dimensional shapes acquired in the shape acquisition procedure, and the predetermined shape is determined. It is preferable that an average shape of the two-dimensional shape is calculated for each cross section, and a three-dimensional shape formed by a set of the average shapes of the two-dimensional shapes is the average shape. If the predetermined cross section is a cross section of an important portion of the mounting portion, the average shape of the important portion can be accurately calculated.

  In the biosensor manufacturing method according to the present invention, each of the plurality of three-dimensional shapes acquired by the shape acquisition procedure is reduced so that the distance between the surfaces of the plurality of three-dimensional shapes acquired by the shape acquisition procedure is reduced. It is preferable to further include an arrangement procedure for arranging between the shape acquisition procedure and the average shape calculation procedure. By further including an arrangement procedure, the average shape calculated in the average shape calculation procedure can be brought close to each of the plurality of three-dimensional shapes acquired in the shape acquisition procedure.

  In the biosensor manufacturing method according to the present invention, in the arrangement procedure, the dispersion or deviation for each position of the surface of the three-dimensional shape is minimized with respect to the distance between the surfaces of the three-dimensional shape acquired in the shape acquisition procedure. Thus, it is preferable to arrange each of the plurality of three-dimensional shapes acquired in the shape acquisition procedure. Each of the three-dimensional shapes acquired by the shape acquisition procedure so that the dispersion or deviation of the distance between the point on the surface of the three-dimensional shape acquired by the shape acquisition procedure and the point on the surface of another three-dimensional shape is minimized. Therefore, in the arrangement procedure, a plurality of three-dimensional shapes acquired in the shape acquisition procedure can be arranged so as to overlap most. Thereby, the average shape calculated in the average shape calculation procedure can be brought closest to each of the plurality of three-dimensional shapes acquired in the shape acquisition procedure.

  In the biosensor manufacturing method according to the present invention, a similar shape extraction that extracts a similar shape in which the distance between the surfaces of the three-dimensional shape is equal to or less than a predetermined distance among the plurality of three-dimensional shapes acquired in the shape acquisition procedure. It is preferable to further have a procedure between the average shape calculation procedure and the mounting portion shape setting procedure. By further including a similar shape extraction procedure, an average shape can be calculated only for similar three-dimensional shapes acquired by the shape acquisition procedure. As a result, the shape of the wearing part can be the average shape of people with similar outer ear shapes, so design the shape of the wearing part suitable for each person with similar outer ear shape. Can do.

  In the biosensor manufacturing method according to the present invention, in the shape acquisition procedure, it is preferable to take in a shape obtained using an elastic impression material with a three-dimensional shape scanner. Since the shape of the outer ear is intricately complicated, it is possible to obtain a precise shape even for a fine portion by making a mold using an elastic impression material. In addition, since the molding is not necessary, the molding can be performed at various places. For this reason, if a plurality of molds are collected and captured by a common three-dimensional scanner, many people can use it.

  In the biosensor manufacturing method according to the present invention, when acquiring the three-dimensional shape of the specific part of one person's outer ear in the shape acquisition procedure, the three-dimensional shape of the specific part of the human outer ear is obtained at a plurality of locations. It is preferable to mold separately and synthesize what was captured by a three-dimensional shape scanner. Since the shape of the outer ear is complex, an accurate three-dimensional shape can be acquired by dividing and acquiring the three-dimensional shape of a specific part of the outer ear.

  In the biosensor manufacturing method according to the present invention, the specific part of the outer ear is preferably a part on the occipital side from the ear canal to the concha cavity. When the mounting portion comes into contact with the occipital region from the ear canal to the concha cavity, the mounting position of the mounting portion on the outer ear can be uniquely determined. Thereby, the reproducibility of the cuff mounting position can be improved. Furthermore, when the cuff is pressurized or depressurized during blood pressure measurement, the reaction force of the pressure or depressurization can be received over a wide range of the concha cavity and the inner wall of the ear canal, thereby suppressing the movement of the cuff during blood pressure measurement. it can.

  In the present invention, since the shape of the mounting portion for mounting the biosensor on the outer ear is an average shape of the three-dimensional shapes of specific parts of a plurality of human outer ears, it is possible to incorporate the characteristics of each person into the shape of the mounting portion. . By incorporating the characteristics of each person into the shape of the mounting part, it is possible to produce a mounting part that fits a specific part of each person's outer ear. As described above, the method for producing a biosensor according to the present invention can produce a mounting portion that fits a specific part of each person's outer ear, and thus can be stably attached to specific parts of a plurality of human outer ears. In addition, it is possible to provide a biosensor including a mounting portion with high reproducibility of the mounting position.

  Embodiments of the present invention will be described with reference to the accompanying drawings. The embodiment described below is an example of the configuration of the present invention, and the present invention is not limited to the following embodiment.

  FIG. 1 is a schematic diagram illustrating an example of a biosensor according to the present embodiment. A biosensor 91 shown in FIG. 1 measures biometric information, and includes a mounting unit 13 that mounts the biosensor 91 on a human outer ear. The biological information is, for example, pulse, pulse wave, electrocardiogram, body temperature, pulse wave blood oxygen saturation, blood flow value, and blood pressure value. In FIG. 1, as an example, a case where the biosensor 91 includes two cuffs 11 and 12 that measure the blood pressure value while sandwiching the tragus 101 is shown. The biosensor 91 further includes an arm 21 that holds the cuff 11 at the tip, an arm 22 that holds the cuff 12 at the tip, an arm connection unit 23 that connects the arm 21 and the arm 22 via a rotation mechanism, and an arm. A cuff adjusting screw 24 that increases or decreases the distance between the cuff 12 and the cuff 12 may be provided.

  The two cuffs 11 and 12 measure the blood pressure value while sandwiching the tragus 101. One cuff 11 of the two cuffs 11, 12 presses the ear canal 102 side of the tragus 101, and the other cuff 12 of the two cuffs 11, 12 presses the face side of the tragus 101. . As the cuffs 11 and 12, for example, inflated or stretchable bags can be used. The tragus 101 is held by the expansion of the bag. Here, the expansion or expansion may be either the cuff 11 or the cuff 12, or both the cuff 11 and the cuff 12. Further, the cuff is an elastic body, and the tragus 101 between the cuff 11 and the cuff 12 may be sandwiched by opening and closing the arm 21 and the arm 22.

  At least one of the cuff 11 and the cuff 12 measures biological information. For example, a detector is accommodated in the cuff 11, and biological information is measured using the detector. When the biological information is a blood pressure value, a photoelectric sensor that detects a pulse wave can be used as the detector. Further, a pressure pulse wave detector that detects a pulse wave from pressure fluctuation may be used.

  The mounting part 13 is for mounting the biosensor on the human outer ear. In FIG. 1, the living body sensor 91 is attached to the outer ear by fixing the attachment portion 13 to the cuff 11 which is one of the two cuffs. As for the mounting part 13, the contact part 31 contacts the specific site | part 104 of an outer ear. Here, the specific part 104 is preferably a part on the occipital side from the external auditory canal 102 to the concha cavity 103. When the mounting part 13 contacts the specific part 104 of the outer ear, the mounting position of the cuff 11 can be uniquely determined, and the change of the position due to the movement of the body can be suppressed. If the reaction force of the cuffs 11 and 12 is applied to the entire concha cavity 103 and the entire inner wall of the ear canal 102, the movement of the mounting positions of the cuffs 11 and 12 during blood pressure measurement can be suppressed. One of the two cuffs to which the mounting portion 13 is fixed may be any of the two cuffs, but is preferably the cuff 11 disposed on the ear canal 102 side.

  Further, when the cuff 11 and the cuff 12 are pressing the tragus 101, pressure is applied to the mounting portion 13 in the direction A from the concha cavity 103 toward the entrance of the ear canal 102. At this time, since the contact portion 31 contacts the inner wall of the occipital side of the ear canal 102 and the concha cavity 103, the movement of the mounting portion 13 in the direction A can be restricted by the curved portion near the entrance of the ear canal 102. . Furthermore, it is preferable that the mounting portion 13 contacts from the concha cavity 103 to the inner wall on the occipital side of the ear canal 102. If contact is made in a wide range, the mounting portion 13 can be further stably mounted, and the cuffs 11 and 12 can be stably fixed. Furthermore, it is preferable that the mounting part 13 also contacts the inner wall on the tragus 101 side. If the mounting portion 13 also contacts the inner wall on the tragus 101 side, the inner side of the inner wall on the tragus 101 side is not easily deformed, so that the movement of the mounting portion 13 in the direction A can be further restricted.

  For example, the mounting portion 13 fixes the cuff 11 which is one of the cuffs in the arrangement direction of the two cuffs 11 and 12, and is recessed on the cuff 11 side at the end in the arrangement direction of the two cuffs 11 and 12. A recess is formed in the contact portion 31. The arrangement direction of the two cuffs can be, for example, a direction connecting the center of the cuff 11 and the center of the cuff 12. When the relative position of the cuff 11 and the cuff 12 changes, it is set as a direction connecting the center of the cuff 11 and the center of the cuff 12 when the tragus 101 is sandwiched or when the cuffs are facing each other. be able to. Since the position of the entrance of the external auditory canal 102 with respect to the tragus 101 varies among individuals, the position of the contact portion 31 does not necessarily have to be on the arrangement direction of the two cuffs 11 and 12. If the contact part 31 is formed on the arrangement direction of the two cuffs 11, 12, a large number of subjects can be worn, so the contact part 31 is formed on the arrangement direction of the two cuffs 11, 12. Preferably it is. Further, the fixing may be a fixing using a mechanical fixing mechanism or may be bonded.

  Furthermore, the mounting part 13 shown in FIG. 1 is preferably hard enough to the human body. That is, it is preferable that the mounting portion 13 does not deform with respect to the pressure applied from the cuff 11. For example, it is preferable that the durometer hardness is Shore A type (JIS K6253) and the hardness is approximately 90 or more. Further, it is preferably a Shore D type (JIS K6253) having a hardness of about 50 or more. This is because when the mounting portion 13 is softer than the human body, the mounting portion 13 may be deformed by the pressure applied from the cuff 11. In this way, the cuffs 11 and 12 can be fixed to the tragus 101 if they are sufficiently hard against the human body.

  In the biosensor manufacturing method according to the present embodiment, in the biosensor 91 that measures biometric information with the outer ear, the portion 31 of the mounting portion 13 that mounts the biosensor 91 on the human outer ear is brought into contact with the specific part 104 of the outer ear. The shape is a shape along the average shape of the specific portions 104 of the plurality of human outer ears. For example, the average shape of the specific part 104 which hits the opposite side of the cuff 11 in contact with the side surface of the external auditory canal 102 of the plurality of human tragus 101 is calculated, and the average shape is used as the shape of the mounting portion 13 for mounting the biosensor 91 to the outer ear. .

  What is important for the biosensor 91 that measures biometric information with the tragus 101 is that the device is not mounted at a unique location due to the movement of the cuffs 11 and 12 during pressure increase / decrease, and the reproducibility of the blood pressure value to be measured decreases. Is to prevent that. When measuring with the tragus, the cuffs 11 and 12 of the biosensor 91 are preferably sandwiched and pressed from both the ear canal 102 side and the face 105 side of the tragus 101. In this case, when the tragus 101 is sandwiched and pressed, the cuffs 11 and 12 are pushed back, and the cuffs 11 and 12 are easily detached from the tragus 101. At this time, if the cuff is fixed to the specific portion 104 that is a curved portion on the back of the head from the external auditory canal 102 to the concha cavity 103, the cuff 11 is unlikely to be detached from the external ear. For this reason, it is preferable to extract a shape that fits the shape of the specific part 104 of the outer ear as much as possible.

  FIG. 2 is a flowchart of a method for producing a biosensor according to this embodiment. The biosensor manufacturing method shown in FIG. 2 includes a shape acquisition procedure S101, an average shape calculation procedure S102, a mounting portion shape setting procedure S103, and a mounting portion molding procedure S106 in this order. Hereinafter, each procedure will be described with reference to FIGS. 1 and 2.

  In the shape acquisition procedure S101, the three-dimensional shapes of the specific parts 104 of a plurality of human outer ears are acquired. The three-dimensional shape is a three-dimensional shape of the surface, for example, three-dimensional unevenness. For example, the acquisition is performed using a stereoscopic camera such as a stereo camera or a three-dimensional scanner. Since stereo matching does not require a complicated device, a three-dimensional shape can be easily obtained. The three-dimensional scanner is preferably a non-contact type such as a laser beam.

  In the shape acquisition procedure S101, when acquiring the three-dimensional shape of the specific part 104 of one person's outer ear, it is preferable to use a three-dimensional shape scanner to capture a model made using an elastic impression material. For example, a specific portion 104 from the external auditory canal 102 to the concha cavity 103 is filled with an elastic impression material, and the shape is taken, and the shape is captured by a three-dimensional shape scanner. Since the shape of the outer ear is intricately complicated, it is possible to obtain a precise shape even for a fine portion by making a mold using an elastic impression material. In addition, since the mold is not necessary, it can be performed in various places. For this reason, if a plurality of molds are collected and captured by a common three-dimensional scanner, many people can use it. Examples of the elastic impression material include a hydrocolloid impression material, an agar impression material, an alginate impression material, a rubbery impression material, a polysulfide rubber impression material, a silicon rubber impression material, and a polyether rubber impression material. The elastic impression material is preferably harmless to the human body. For example, an alginate impression material or a silicon impression material is preferred.

  In the shape acquisition procedure S101, when acquiring the three-dimensional shape of the specific part 104 of one person's outer ear, the three-dimensional shape of the specific part 104 of the person's outer ear is divided into a plurality of locations, and the three-dimensional shape scanner It is preferable to synthesize what is taken in. Since the shape of the outer ear is complicated, an accurate three-dimensional shape can be acquired by dividing and acquiring the three-dimensional shape of the specific part 104 of the outer ear.

  FIG. 3 shows an example of the three-dimensional shape of the outer ear acquired in the shape acquisition procedure S101. FIG. 3 shows a three-dimensional surface shape of the outer ear from the ear canal 102 to the concha cavity 103. In the shape acquisition procedure S101, it is preferable to extract the three-dimensional shape of the specific part 104 of the outer ear from the acquired three-dimensional shape of the outer ear. The most important part for the fit of the wearing part to the outer ear is the specific part 104 of the outer ear. It is possible to fit as much as possible to the shape of the specific part 104 of the outer ears of a plurality of persons by deleting an unnecessary part while leaving an important part for the fit. Therefore, it is possible to provide a mounting portion that can be applied to more users.

  In the average shape calculation procedure S102, an average shape for a plurality of three-dimensional shapes acquired in the shape acquisition procedure S101 is calculated. As a first example of the average shape calculation procedure S102, for example, calculation is performed using a product-sum operation or morphing of a plurality of three-dimensional shapes acquired in the shape acquisition procedure S101. Here, the product-sum operation for obtaining an average shape is to obtain an average by a product (AND) or sum (OR) process in a Boolean operation. For example, a common shape is extracted by integration, and the most likely shape formed by the common shape is calculated as an average shape. In addition, the product-sum operation for obtaining the average shape may obtain the average by product and sum processing. For example, the average may be obtained by sequentially adding the common portions of the images. The integration of images is, for example, superimposing a large number of images, leaving overlapping portions, and deleting non-overlapping portions. Deletion is made transparent, for example. The image summation is, for example, adding a non-overlapping portion excluding the background by superimposing a large number of images. By using the product-sum operation, an average shape of a plurality of three-dimensional shapes can be obtained with a simple configuration. Morphing for obtaining an average shape is the most probable shape from a plurality of intermediate shapes that are processed so as to smoothly change from one shape to the other and complement the gap between one shape and the other. Is calculated as an average shape. By calculating a plurality of intermediate shapes for each of the plurality of three-dimensional shapes, an average shape of the plurality of three-dimensional shapes can be calculated. The intermediate shape may be a primary complement between one shape and the other, or may be a secondary or higher complement. The average shape may be calculated by averaging the sample data. For example, by calculating an average value of data for each pixel, an average shape that is the most likely shape can be calculated. Further, an average value may be calculated for each coordinate such as a pixel, and a shape formed by the average value may be used as the average shape. For example, modeling software that can handle 3D CAD or 3D shape data is used in the average shape calculation procedure S102. If the relative positional relationship of each polygon data is known as well as software that handles a three-dimensional shape, it can be performed by manual numerical calculation.

  FIG. 4 is a schematic diagram illustrating a second example of the average shape calculation procedure S102. In FIG. 4, each of the three-dimensional surface shapes 210 and 220 acquired in the shape acquisition procedure S101 is formed of a plurality of planes. The plane is, for example, a polygon. In FIG. 4, only the plane 211 and the plane 212 of the plurality of planes forming the surface shape 210 are shown. Further, only the plane 221 and the plane 222 among the plurality of planes forming the surface shape 220 are shown. Further, FIG. 4 shows a cross section in the normal direction of the plane 211 passing through the center point 215 of the plane 211.

  In the second example of the average shape calculation procedure S102, a plurality of planes 211, 212, 221, and 222 that form the three-dimensional surface shapes 210, 220, and 230 for each of the plurality of three-dimensional shapes acquired in the shape acquisition procedure S101. , 231 and 232 are extracted. Then, a perpendicular line is extended from the center point 215 of the plane 211 in the normal direction of the plane 211, and respective distances 216 and 217 until the perpendicular line intersects with other three-dimensional surface shapes 220 and 230 are calculated. Here, it is preferable to exclude those whose perpendicular from the plane does not intersect with other polygons. Then, an average position 218 that is an average of the distances 216 and 217 to the planes 220 and 230 forming another three-dimensional shape on the normal line of the plane 211 is calculated. Similarly, the average position 219 is calculated for the plane 212, and the three-dimensional shape formed by the average position 218 and the set of the average positions 219 is defined as the average shape. Since the average shape can be calculated by extracting the surface shape data of the three-dimensional shape, the data capacity for expressing the three-dimensional shape can be reduced.

  In the second example of the average shape calculation procedure S102, the average shape is calculated similarly for the surface shape 220 and the surface shape 230, the average shape between the average shapes is calculated, and the final shape is set as the average shape. Is preferred. Further, it is preferable to perform polygon division when calculating the average position for each plane. The calculation from the set of average positions to the three-dimensional shape is preferably performed by interpolation by specifying a characteristic of a polynomial curve such as a Bezier curve or interpolation by linear interpolation. Moreover, it is preferable to calculate a three-dimensional shape by drawing a curved surface on a mesh formed by a set of average positions. It is also preferable to interpolate a mesh formed by a set of average positions.

  If processing cannot be performed in the state of polygon data, the same processing is performed on the solid data that fills the tragus side, and then the surface that fills the tragus side may be removed. As a result, shapes that can be worn by the user having all the ear-canal-concha cavity shapes in this combination are extracted.

  FIG. 5 is a schematic diagram illustrating a third example of the average shape calculation procedure S102. FIG. 5 shows two-dimensional shapes 251, 252, and 253 in a predetermined cross section of the three-dimensional surface shape acquired in the shape acquisition procedure S101. The two-dimensional shape is indicated by a two-dimensional curve obtained by extracting the surface shape. The two-dimensional shapes 251, 252, and 253 are obtained by extracting an edge from the two-dimensional shape of the cross section and deleting the solid part on the tragus (reference numeral 101 in FIG. 1) side or the ear canal (reference numeral 102 in FIG. 1) side. It is preferable to extract the shape. Here, the two-dimensional shape may be a set of pixels remaining as an edge, but may be converted into a polynomial curve such as a Bezier curve or a spline curve.

  In the third example of the average shape calculation procedure S102, two-dimensional shapes 251, 252, and 253 in a predetermined cross section are extracted for each of a plurality of three-dimensional shapes acquired in the shape acquisition procedure S101. Here, the predetermined cross section is, for example, a cross section of the mounting portion 13 disposed in a plane passing through the centers of the cuffs 11 and 12 and the arm connecting portion 23 or a cross section parallel to the cross section. It is preferable to calculate a two-dimensional shape for a plurality of cross sections, and the interval between the cross sections is preferably short. Then, an average shape of a two-dimensional shape is calculated for each predetermined cross section. For example, the average shape of the two-dimensional shapes 251 252 253 is calculated. The average shape is calculated by averaging for each coordinate axis, for example. In addition, it is calculated from the average distance between the curves of the two-dimensional shapes 251 252 253. A three-dimensional shape formed by a set of two-dimensional average shapes is preferably an average shape. The calculation of the three-dimensional shape from the average shape of a plurality of two-dimensional shapes is preferably performed by interpolation, linear interpolation or morphing by specifying a characteristic of a polynomial curve such as a Bezier curve.

  In the mounting portion shape setting procedure S103, the shape of the portion 31 that is brought into contact with the specific part 104 of the outer ear in the mounting portion 13 where the biosensor 91 is mounted on the outer ear is the shape along the average shape calculated in the average shape calculating procedure S102. Set to. Here, the shape along the average shape is, for example, in contact with the specific part 104 of the outer ear of the mounting portion 13 when the mounting portion 13 is matched with the average shape calculated in the average shape calculating procedure S102. It is the shape which contacts the part to be made evenly. The shape along the average shape is preferably a shape obtained by inverting the unevenness of the average shape. Moreover, it is preferable that it is a shape which contacts without a space | gap, when the mounting part 13 is mounted | worn with an outer ear. There may be a non-contact portion between the average shape and the portion of the mounting portion 13 that is in contact with the specific part 104 of the outer ear. For example, it is preferable that unevenness is provided so as not to prevent sweating and skin respiration.

  In the mounting portion forming procedure S106, the shape of the mounting portion 13 is formed into the shape set in the mounting portion shape setting procedure S103. For example, a mold having the shape set in the mounting portion shape setting procedure S103 is produced, and the raw material of the mounting portion 13 is poured into the mold and molded. Moreover, you may shape | mold by extrusion molding. The raw material of the mounting portion 13 is, for example, resin or rubber. The mounting portion 13 is preferably one that has little influence on the human body, for example, silicon.

  As described above, in the manufacturing method of the biosensor 91 according to the present embodiment, the shape of the mounting portion 13 that mounts the biosensor on the outer ear is the average shape of the three-dimensional shapes of specific parts of the plurality of human outer ears. . Since the shape of the mounting portion 13 incorporates the characteristics of each person, the mounting portion 13 that fits each of a plurality of people can be produced even if the specific part 104 of the outer ear varies among individuals. . Thereby, the biosensor 91 according to the present embodiment includes the mounting portion 13 that can be stably mounted on the specific part 104 of the outer ear and has high reproducibility of the mounting position for each of a plurality of persons. be able to.

  Furthermore, since the biosensor 91 according to the present embodiment includes the attachment unit 13 that can be stably attached to the specific part 104 of the outer ear for each of a plurality of persons, It is possible to stabilize the mounting position of each human biosensor 91. Accordingly, each person can be prevented from shifting the mounting position of the biosensor 91 when measuring biometric information. In addition, since the biosensor 91 includes the mounting portion 13 with high reproducibility of the mounting position for each of a plurality of people, the reproducibility of the mounting position of the biosensor 91 can be improved for each person. Therefore, it can be set as the biosensor 91 which can measure biometric information with high reproducibility for each person.

  In the biosensor manufacturing method according to the present embodiment, it is preferable to further include an arrangement procedure S104 between the shape acquisition procedure S101 and the average shape calculation procedure S102. In the arrangement procedure S104, the three-dimensional shapes acquired in the shape acquisition procedure S101 are arranged so as to overlap each other. For example, each of the plurality of three-dimensional shapes acquired in the shape acquisition procedure S101 is arranged so that the distance between the surfaces of the plurality of three-dimensional shapes acquired in the shape acquisition procedure S101 is reduced. The distance between the surfaces is preferably arranged so that the distance between a part of the surfaces of a predetermined three-dimensional shape is small. A part of the surface of the predetermined three-dimensional shape includes a part of the specific portion 104 of the outer ear on the side of the ear canal 102 side, a portion to be disposed in the vicinity of the entrance of the ear canal 102, and the concha The end portion on the 103 side is preferable. By further including the arrangement procedure S104, the average shape calculated in the average shape calculation procedure S102 can be approximated to each of the plurality of three-dimensional shapes acquired in the shape acquisition procedure S101. Here, when the biosensor manufacturing method according to the present embodiment further includes a similar shape extraction procedure S105, the arrangement procedure S104 is preferably before the similar shape extraction procedure S105. By being before the similar shape extraction procedure S105, the similar shape can be extracted more accurately in the similar shape extraction procedure S105.

  For example, in the arrangement procedure S104, as shown in FIG. 4 described in the average shape calculation procedure S102 described above, from the center point 215 of the plane 211 that forms the surface shape 210 of the outer ear three-dimensional shape, The distance to the plane 221 forming the dimensional surface shape 220 is calculated and arranged so that the distance for each plane becomes small. Further, in the arrangement procedure S104, as shown in FIG. 5 described in the average shape calculation procedure S102 described above, the two-dimensional surface in the predetermined cross section is obtained for each of the plurality of three-dimensional surface shapes acquired in the shape acquisition procedure S101. The shapes are extracted and arranged for each of the surface shapes of the plurality of three-dimensional shapes acquired in the shape acquisition procedure S101 so that the distance between the two-dimensional shapes becomes small.

  In the arrangement procedure S104, the distance between the surfaces of the three-dimensional shape acquired in the shape acquisition procedure S101 is a plurality of pieces acquired in the shape acquisition procedure S101 so that the variance or deviation for each position of the surface of the three-dimensional shape is minimized. It is preferable to arrange each of the three-dimensional shapes. The three-dimensional shape acquired in the shape acquisition procedure S101 so that the dispersion or deviation of the distance between the point on the surface of the three-dimensional shape acquired in the shape acquisition procedure S101 and the point on the surface of another three-dimensional shape is minimized. Therefore, in the arrangement procedure S104, the plurality of three-dimensional shapes acquired in the shape acquisition procedure S101 can be arranged so as to have the largest number of overlapping portions. Thereby, the average shape calculated in the average shape calculation procedure S102 can be brought closest to each of the plurality of three-dimensional shapes acquired in the shape acquisition procedure S101.

  The position of the surface of the three-dimensional shape is, for example, each coordinate of a point forming the vertex of the center point 215 or the center point 215 of the plane shown in FIG. 4 or the curve of the two-dimensional shape 251 shown in FIG. If the center point 215 of the plane shown in FIG. 4, the distance from the three-dimensional surface shape 210 of the outer ear to the three-dimensional surface shape 220 of the human outer ear is calculated for each plane, The three-dimensional surface shape 210 of the outer ear and the three-dimensional surface shape 220 of the human outer ear are arranged so that the deviation is minimized.

  In the biosensor manufacturing method according to the present embodiment, it is preferable to further include a similar shape extraction procedure S105 between the average shape calculation procedure S102 and the mounting portion shape setting procedure S103. In the similar shape extraction procedure S105, a cluster in which similar shapes are collected from the plurality of three-dimensional shapes acquired in the shape acquisition procedure S101 is created. And it transfers to average shape calculation procedure S102 for every cluster. That is, the average shape calculation procedure S102 is performed for each cluster. By further including the similar shape extraction procedure S105, the average shape can be calculated only for the three-dimensional shape acquired in the shape acquisition procedure S101. As a result, the shape of the wearing part can be the average shape of people with similar outer ear shapes, so design the shape of the wearing part suitable for each person with similar outer ear shape. Can do.

  In the similar shape extraction procedure S105, for example, a similar shape in which the distance between the surfaces of the three-dimensional shape is a predetermined distance or less is extracted from the plurality of three-dimensional shapes acquired in the shape acquisition procedure S101. The distance between the surfaces of the three-dimensional shape can be a normal direction of the surfaces or a distance on a coordinate axis. For the distance between the surfaces of the three-dimensional shape, for example, n distances to other three-dimensional shapes calculated for each polygon are calculated, and a certain percentage or more of the calculated n distances is within a predetermined distance. Similar shape when fit. For example, as shown in FIG. 5, n distances between the two-dimensional shape 252 and the two-dimensional shape 253 are calculated, and similar when a certain percentage or more of the calculated n distances is within a predetermined distance. Shape. The distance between the two-dimensional shape 252 and the two-dimensional shape 253 may be on the same axis or in the normal direction of the two-dimensional shape 252. Here, the certain ratio is 80% or more, desirably 90%. The predetermined distance is preferably 1 mm. When the distance between the surfaces of the three-dimensional shape is within 1 mm, the shape of the mounting portion can be designed to be the shape of the mounting portion suitable for each person who has a similar shape of the outer ear.

  First, in the shape acquisition procedure S101, a part of the occipital region from the external auditory canal to the concha is filled with an elastic impression material to perform molding, and the shape is obtained by a three-dimensional shape scanner (manufactured by Konica Minolta Sensing, non-contact type). 3D digitizer, VIVID 910). The captured shape is hereinafter referred to as an external auditory canal-concha cavity shape for simplicity. Then, since it is necessary to obtain a shape that fits as much as possible to the external auditory canal-concha conchasal shape of multiple persons, unnecessary portions other than the external auditory canal-concha cavity shape were deleted.

  In the arrangement procedure S104, modeling software (RapidForm 2004, manufactured by Inus Technology) was used to arrange a plurality of captured external auditory canal-concha conchae space shape data so that most of the shapes overlapped visually. Then, the arrangement of a plurality of external auditory canal-concha conchae shapes was optimized using the “alignment (auto)” function of the “scan” workbench.

  In the similar shape extraction step S105, clustering is performed on combinations of data of the external auditory canal-concha cavity shape data in which the average distance between polygons of the external auditory canal and concha cavity shape is within 1 mm.

  In the mounting part shape setting step S103, the “polygon” workbench “Boolean operation, product of shell and shell” of the modeling software (Inus Technology, RapidForm 2004) is used to calculate the external auditory canal-concha conchae shape data in the cluster. The average shape was calculated.

  As a result of performing the shape acquisition procedure S101, the placement procedure S104, and the similar shape extraction procedure S105 for 15 subjects, the four ear canal and concha cavity shapes corresponded to the same cluster. Then, the wearing part shape setting procedure S103 was performed for the four ear canal-concha conchasal shapes of the same cluster, and the average shape was calculated. Here, for simplicity, the average shape is called a merge shell. 6, 7, 8, and 9 are the results of measuring the distance between the ear canal-concha conchae shape and the merge shell for each of the four ear canal—concha conchae shapes in the same cluster.

  FIG. 10 shows the first result of detecting the pulse wave during blood pressure measurement, where (a) shows the case where the merge shell is not attached and (b) shows the case where the merge shell is attached. In FIG. 10A, 511 is a photoelectric volume pulse wave, 512 is a cuff pressure, and 513 is a light reception level. In FIG. 10B, 515 indicates a photoelectric volume pulse wave, 516 indicates a cuff pressure, and 517 indicates a light reception level.

  FIG. 11 shows the second result of detecting the pulse wave at the time of blood pressure measurement. FIG. 11A shows the case where the merge shell is not attached, and FIG. 11B shows the case where the merge shell is attached. In FIG. 11A, 521 indicates a photoelectric volume pulse wave, 522 indicates a cuff pressure, and 523 indicates a light reception level. In FIG. 11B, 525 indicates the photoelectric volume pulse wave, 526 indicates the cuff pressure, and 527 indicates the light reception level.

  FIGS. 12A and 12B show the ninth result of detecting a pulse wave during blood pressure measurement. FIG. 12A shows the case where the merge shell is not attached, and FIG. 12B shows the case where the merge shell is attached. In FIG. 12A, 591 is a photoelectric volume pulse wave, 592 is a cuff pressure, and 593 is a light receiving level. In FIG. 12B, 595 indicates a photoelectric volume pulse wave, 596 indicates a cuff pressure, and 597 indicates a light reception level.

  From the results of FIG. 10, FIG. 11 and FIG. 12, when the sphygmomanometer does not have a merge shell, none of the light reception level, cuff pressure and photoelectric volume pulse wave is reproducible, but when fixed by the merge shell, It was found that all of the received light level, cuff pressure, and photoelectric volume pulse waveform were reproducible. In particular, regarding the waveform of the photoelectric volume pulse wave, the time point at which the pulse wave appears and the time point at which the maximum amplitude is reached are important. When attention is paid to these time points, when the merge shell shown in FIGS. 11 (a) and 12 (a) is not provided, the time point at which the maximum amplitude of the pulse wave cannot be determined, and the blood pressure value cannot be detected. ing. However, when the sphygmomanometer is attached to the outer ear by the merge shell shown in FIG. 10 (b), FIG. 11 (b) and FIG. The time of the maximum amplitude of the photoelectric volume pulse can be detected with high reproducibility. Therefore, the blood pressure value can be measured with good reproducibility.

  Since the biological sensor according to the present invention can measure biological information from the outer ear, it can also be used for beauty and health applications.

It is a schematic diagram which shows an example of the biosensor which concerns on this embodiment. It is a flowchart of the manufacturing method of the biosensor which concerns on this embodiment. An example of the three-dimensional shape of the outer ear acquired in the shape acquisition procedure S101 is shown. It is a schematic diagram which shows the 2nd example of average shape calculation procedure S102. It is a schematic diagram which shows the 3rd example of average shape calculation procedure S102. It is the result of having measured the distance of an external auditory canal-concha conchasal shape and a merge shell about each of four external auditory canal-concha conchasal shape of the same cluster. It is the result of having measured the distance of an external auditory canal-concha conchasal shape and a merge shell about each of four external auditory canal-concha conchasal shape of the same cluster. It is the result of having measured the distance of an external auditory canal-concha conchasal shape and a merge shell about each of four external auditory canal-concha conchasal shape of the same cluster. It is the result of having measured the distance of an external auditory canal-concha conchasal shape and a merge shell about each of four external auditory canal-concha conchasal shape of the same cluster. It is the result of the 1st time which detected the pulse wave at the time of blood-pressure measurement, (a) shows the case where a merge shell is not mounted | worn, (b) shows the case where a merge shell is mounted | worn. It is the result of the 2nd time which detected the pulse wave at the time of blood-pressure measurement, (a) shows the case where a merge shell is not mounted | worn, (b) shows the case where a merge shell is mounted | worn. It is the result of the ninth time when the pulse wave at the time of blood pressure measurement is detected. (A) shows the case where the merge shell is not attached, and (b) shows the case where the merge shell is attached.

Explanation of symbols

DESCRIPTION OF SYMBOLS 11, 12 Cuff 13 Mounting part 21, 22 Arm 23 Arm connection part 24 Cuff adjustment screw 31 Contact part 91 Biosensor 101 Tragus 102 External auditory canal 103 Concha cavity 104 Specific part of outer ear 105 Face A direction

Claims (11)

  The shape of the portion of the mounting portion that mounts the biological sensor for measuring biological information on the outer ear of the human being to be in contact with the specific portion of the outer ear is set to a shape that conforms to the average shape of the specific portion of the outer ear of a plurality of humans. A method for producing a biosensor characterized by the above. A shape acquisition procedure for acquiring a three-dimensional shape of a specific part of a plurality of human outer ears;
An average shape calculation procedure for calculating an average shape of a plurality of three-dimensional shapes acquired in the shape acquisition procedure;
A mounting unit that sets a shape of a portion that contacts a specific part of the outer ear of a mounting unit that mounts a biometric sensor for measuring biological information on the outer ear to a shape along the average shape calculated in the average shape calculation procedure. A method for producing a biosensor, comprising: a shape setting procedure.   The average shape calculation procedure includes calculating an average shape of the plurality of three-dimensional shapes using a product-sum operation or morphing of the plurality of three-dimensional shapes acquired in the shape acquisition procedure. A method for producing the biosensor as described.   In the average shape calculation procedure, a plurality of planes forming the three-dimensional shape are extracted for each of the plurality of three-dimensional shapes acquired in the shape acquisition procedure, and the other planes on the normal line of the plane from the center of the plane The average position at which the distance to the plane forming the three-dimensional shape is averaged is calculated for each plane, and the three-dimensional shape formed by the set of the average positions is defined as the average shape. 3. A method for producing the biosensor according to 2.   In the average shape calculation procedure, a two-dimensional shape in a predetermined cross section is extracted for each of a plurality of three-dimensional shapes acquired in the shape acquisition procedure, and the average shape of the two-dimensional shape is determined for each predetermined cross section. The biosensor manufacturing method according to claim 2, wherein a three-dimensional shape formed by a set of average shapes of the two-dimensional shapes is calculated as the average shape.   An arrangement procedure for arranging each of the plurality of three-dimensional shapes acquired by the shape acquisition procedure so that distances between the surfaces of the plurality of three-dimensional shapes acquired by the shape acquisition procedure are reduced. The method for producing a biosensor according to claim 2, further comprising: between the average shape calculation procedure and the average shape calculation procedure.   In the arrangement procedure, with respect to the distance between the surfaces of the three-dimensional shape acquired in the shape acquisition procedure, a plurality of acquired in the shape acquisition procedure so that the variance or deviation for each position of the surface of the three-dimensional shape is minimized. Each of the said three-dimensional shape is arrange | positioned, The manufacturing method of the biosensor of Claim 6 characterized by the above-mentioned.   Among the plurality of three-dimensional shapes acquired in the shape acquisition procedure, a similar shape extraction procedure for extracting a similar shape in which the distance between the surfaces of the three-dimensional shape is a predetermined distance or less, the average shape calculation procedure and the mounting The biosensor manufacturing method according to claim 2, further comprising a part shape setting procedure.   The method for producing a biosensor according to claim 2, wherein in the shape acquisition procedure, a shape taken using an elastic impression material is captured by a three-dimensional shape scanner.   In the shape acquisition procedure, when acquiring a three-dimensional shape of a specific part of a person's outer ear, the three-dimensional shape of the specific part of the person's outer ear is divided into a plurality of locations, and a three-dimensional shape scanner is used. The biosensor production method according to claim 9, wherein the taken-in one is synthesized. The method for producing a biosensor according to claim 1, wherein the specific part of the outer ear is a part on the occipital side from the ear canal to the concha cavity.

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